CONDITIONAL RESOLUTIONS IN THE AMNOG EARLY BENEFIT ASSESSMENT

Author(s)

Assmann G, Schmidt U, Drechsler M, Pfannkuche M
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany

OBJECTIVES Since 2011 the early benefit assessment (EBA) is mandatory to obtain reimbursement for new drugs in Germany. By law EBA of the G-BA (Federal Joint Committee) can be conditional for a certain period of time. This study explores the number, duration and rationale of conditional G-BA resolutions. Furthermore the provided, later given (during statement process), accepted and additionally requested study data is analysed in this context. METHODS AMNOG dossiers and resolutions of the G-BA including justifications until June 2014 were reviewed for relevant information and analysed with special regard to the submitted and accepted study data. Drugs which were directly allocated to a fixed-reference price group were excluded. RESULTS CONCLUSIONS From 2011 on an increased number of resolutions and especially cancer drugs were conditional. Only in a few cases G-BA defined in the resolution which specific data has to be shown in the re-assessment. In these cases the requirements concerning further evidence were not part of the G-BA voting. As currently just one drug was re-assessed, no conclusions can be drawn how re-assessment changes the extent or certainty of additional benefit.

Conference/Value in Health Info

2014-11, ISPOR Europe 2014, Amsterdam, The Netherlands

Value in Health, Vol. 17, No. 7 (November 2014)

Code

PHP225

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Multiple Diseases

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